Consumer Medicine Information (unregistered)

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Consumer Medicine Information (unregistered)

SAABI Vaporised Nicotine Delivery System®

 

SAABI Nicotine Delivery Device.

SAABI Nicotine Delivery Pods, 2% 20mg/ml

SAABI Nicotine Delivery Pods, 1.3% 13mg/ml

SAABI Nicotine Delivery Pods, 0% 0mg/ml

SAABI Nicotine Delivery Device® SAABI Nicotine Delivery Pods®

 

Variable rate controlled vaporised nicotine pod and device.

 

 

 

 

SAABI NZ PTY LIMITED AND ITS SUBSIDIARIES ATTEST NO CLAIM TO ANY THERAPEUTIC BENEFIT IN RELATION TO ITS PRODUCTS OR SERVICES

 

WARNING: This product may be hazardous to health and is intended for use by adult smokers. Keep out of reach of children and pets. SAABI products are not suitable for use by persons under the age of 18+ or 21+ Depending on your country/region, pregnant or breastfeeding women, or persons who are sensitive or allergic to nicotine, and should be used with caution by persons with or at a risk of an unstable heart condition or high blood pressure.

What is in this leaflet: This leaflet answers some common questions about the SAABI Nicotine Delivery Device® SAABI Nicotine Delivery Pods® combined SAABI Vaporised Nicotine Delivery System®.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your pharmacist or doctor will be able to advise you about the risks and benefits of using SAABI Nicotine Delivery Device® SAABI Nicotine Delivery Pods® or SAABI Vaporised Nicotine Delivery System®.

If you have any concerns about using this unregistered medicine, ask your pharmacist or doctor.

Keep this leaflet with the unregistered medicine. You may need to read it again.

What is SAABI Vaporised Nicotine Delivery System® used for:

SAABI Nicotine Delivery Device® SAABI Nicotine Delivery Pods® SAABI Vaporised Nicotine Delivery System® could help you stop smoking. You probably know that smoking is a very difficult habit to break. There are two sides to quitting smoking. The first is the psychological dependence on cigarettes. You have probably smoked for many years and smoking has become an important part of your life.

The other side is the physical addiction to nicotine. Cigarettes contain nicotine, and your body has become dependent on nicotine. SAABI Vaporised Nicotine Delivery System® delivers nicotine into your bloodstream. Using SAABI Vaporised Nicotine Delivery System® could help to gradually reduce the amount of nicotine your body craves each day.

Counselling is available from various groups such as Quitline. To get the best out of SAABI Vaporised Nicotine Delivery System® we encourage you to enrol in one of these groups. Quit SAABI Vaporised Nicotine Delivery System® is not intended for short periods, e.g. plane trips or other times when you cannot smoke. It is designed to help you quit smoking, not as a substitute for smoking.

SAABI Vaporised Nicotine Delivery System® works most effectively when you have a strong personal commitment to stop smoking. You cannot rely on SAABI Vaporised Nicotine Delivery System® alone to break the habit. SAABI Vaporised Nicotine Delivery System® could help relieve many nicotine withdrawal symptoms and cravings.

 

 

 

Before you use SAABI Vaporised Nicotine Delivery System®:

When you must not use it: Do not use SAABI Vaporised Nicotine Delivery System® if:

  •  you are under 18 or 21 years old.
  •  you are a non-smoker
  •  you have an allergy to nicotine or to any component of the System
  •  the packaging is torn or shows signs of tampering.

There are no health benefits to smoking. It is always better to give up smoking and using SAABI Vaporised Nicotine Delivery System® could help. In general, any possible side effects associated with Electronic Nicotine Delivery Systems (ENDS) are far outweighed by the well-established dangers of continuing to smoke.

If you are in hospital because of a heart attack, severe heart rhythm disorders or a stroke, you should try to quit smoking without using (ENDS) unless your doctor tells you to use it. Once you are discharged from the hospital, you may use (ENDS) in consultation with your doctor.

Before you start to use it: Talk to your doctor and ask for his/her advice before using SAABI Vaporised Nicotine Delivery System® if:

  •  you have had a recent heart attack or stroke
  •  you have angina (chest pain) that is not well controlled or is getting worse
  •  you have severe arrhythmia (irregular heartbeat).

Talk to your doctor or pharmacist and ask for his/her advice before using SAABI Vaporised Nicotine Delivery System® if:

  •  you have severe high blood pressure
  •  you have other heart or blood vessel disease
  •  you have diabetes
  •  you have kidney or liver problems
  •  you have hyperthyroidism (a disorder of the thyroid gland)
  •  you have phaeochromocytoma (a tumour of the adrenal gland)
  •  you are pregnant or breast-feeding

If you require further advice, you should talk with your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, or health food shop.

Your doctor and pharmacist will be able to advise you if stopping smoking may affect the way these medicines work.

Driving or operating machinery: There is no evidence of any risk associated with driving or operating machinery if SAABI Vaporised Nicotine Delivery System® is used according to the recommended dose but remember that smoking cessation can cause behavioural changes.

If you are pregnant: Ideally you should not use this system while you are pregnant, and you should stop smoking without using Electronic Nicotine Delivery Systems (ENDS). Nicotine in any form may cause harm to your unborn baby.

If you are breast-feeding: Nicotine is excreted in breast milk in quantities that may affect the child even in therapeutic doses. Like smoking, Electronic Nicotine Delivery Systems (ENDS) should be avoided during breast-feeding. Do not use SAABI Vaporised Nicotine Delivery System® if you are breast-feeding.

How to get started with SAABI Vaporised Nicotine Delivery System®

How to get started: It is probably best to nominate a specific day that you will stop smoking. It may be helpful to:

  1. Try to choose a day when you will not be where others are smoking.
    2. Choose a day with as little stress as possible.
    3. Choose a day not too far in the future.

Tell your family and friends that you have set this target “quit day”.
This is the day you take complete control of your habit and become a non-smoker.

How much to use:  A course of SAABI Vaporised Nicotine Delivery System® is determined in consultation with your doctor and may vairy. Where one pod is used each day for the duration of the course. Each pod is consumed in one day (24 hours). As your course progresses, the aim is to use a lower strength pod as your body’s desire for nicotine decreases. SAABI Nicotine Delivery Pods® come in 3 nicotine dosage strengths, SAABI Vaporised Nicotine Delivery System® Step 1 A: (20mg/ml / 24 hours) OR B: (13mg/ml / 24 hours), Step 2 A: (13mg/ml / 24 hours) OR B: (0mg/ml / 24 hours). and A: Step 3 (0mg/ml / 24 hours) OR B: (Abstinence). The correct strength for you to start on depends on how many cigarettes you smoke each day and be directed by your doctor.

 

Instructions are provided below for each of the two programs. Program A is for people who smoke 20 or more cigarettes each day and Program B is for people who smoke less than 20 cigarettes each day. Your doctor will choose the correct program for you.

If you have a previous medical condition your doctor may choose to vary the dosage as appropriate.

Choose the program that may be right for you:

Program A: If you smoke 20 or more cigarettes each day:

Months 1 – 6: 1. Stop cigarette smoking and use one 20mg/ml SAABI Nicotine Delivery Pods® each day for 6 months.

Months 6 – 12: 2. After you should no longer be smoking cigarettes and can move on to 1.3mg/ml SAABI Nicotine Delivery Pods® each day for 6 months. However, if you are still smoking, consult your doctor or pharmacist.

Months 12 – 18: 3. After you should no longer be smoking cigarettes and can move on to 0 mg/ml SAABI Nicotine Delivery Pods® each day for 6 months. However, if you are still smoking, consult your doctor or pharmacist.

Months 18 – Beyond: 4.  After 18 months you should stop using the pods. You have become a non-smoker. Congratulations!

Program B: If you smoke less than 20 cigarettes each day:

Months 1 – 6: 1. Stop cigarette smoking and use one 1.3mg/ml SAABI Nicotine Delivery Pods® each day for 6 months.

Months 6 – 12: 2. After you should no longer be smoking cigarettes and can move on to 0 mg/ml SAABI Nicotine Delivery Pods® each day for 6 months. However, if you are still smoking, consult your doctor or pharmacist.

Months 12 – Beyond: 3. After 12 months you should stop using the pods. You have become a non-smoker. Congratulations!

How to use SAABI Vaporised Nicotine Delivery System®

Inserting a pod: Simply push the pod gently into place in the top of the device until you feel a click. The LED indicator light in the centre of the device will illuminate for one second after the pod is properly inserted. The pod is translucent so that the e-liquid level can be checked, most easily with pod removed and held upright. When e-liquid runs out, simply replace the old pod with a new one.

Vaping: Inhale gently on the pod mouthpiece and it will begin to produce vapor. The LED will illuminate while vapor is being produced. The colour of LED changes according to the remaining battery life as follows:

Green 100% to 50% Yellow 50% to 20% Red 20% to 0%

Charging the battery: To charge the battery, connect the device to a suitable USB power supply using the USB Type- C cable provided. The LED will illuminate in the colour according to the battery life during charging. When fully charged, the LED illuminate in green colour until the USB Type-C cable is unplugged.

Cleaning and maintenance: The battery can be cleaned using a soft dry cloth or care should be taken to avoid getting the Device or pod wet. The pod connection point in the battery can be cleaned carefully using a dry cotton swab.

Specifications:

Size: 100mm X19mm X6.5mm
Battery Capacity: 200 mAh
Charging Time: 30 minutes
Battery Indicator: LED Green, Yellow, Red
Cartridge Capacity: 0.8 ml
Resistance: 1.6 ohm
Weight: 15.5g
Material: Food Grade PTCG(Cartridge)
Aircraft Grade Aluminium (Battery)

While you are using SAABI Vaporised Nicotine Delivery System®

Things you must do:

Use SAABI Nicotine Delivery Device® and SAABI Nicotine Delivery Pods® exactly as instructed. If you follow these recommendations you should get the full benefit of SAABI Vaporised Nicotine Delivery System®.

‘Avoid contact with eyes’

‘Avoid contact with skin’

Stop smoking completely while using SAABI Vaporised Nicotine Delivery System®.  You may have increased side effects if you continue to smoke while using SAABI Vaporised Nicotine Delivery System®. Tell your doctor or pharmacist if you continue to smoke while you are using SAABI Vaporised Nicotine Delivery System®.

Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.

Things you must not do:

Do not stop using SAABI Vaporised Nicotine Delivery System® suddenly. You may get side effects similar to those you would get if you stopped smoking suddenly.

Side Effects:

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using SAABI Vaporised Nicotine Delivery System®.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • headache
  • dizziness
  •  nausea (feeling sick)
  •  sleep disturbance.

These side effects are generally mild.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Keep SAABI Vaporised Nicotine Delivery System® out of reach of children and pets.

Nicotine is a highly toxic substance and could be life threatening to children. Each SAABI Nicotine Delivery Pods® sealed in a child-resistant blister pack. Please take particular care to dispose of the used pods carefully.

If you use too much (overdose)

If you smoke or use other products containing nicotine while using SAABI Vaporised Nicotine Delivery System®, you may suffer an overdose of nicotine. However, if used correctly, nicotine overdose is unlikely.

The signs and symptoms of nicotine overdosage include pallor, sweating, nausea, salivation, vomiting, stomach upset, diarrhoea, headache, dizziness, hearing and vision disturbances, tremor, confusion, weakness, fainting and breathing difficulties.

If overdosage is suspected, discontinue use immediately. Depending on the severity of the symptoms, seek advice from your pharmacist, doctor or Accident and Emergency at your nearest hospital.

Children: It is very important to keep both used and unused SAABI Nicotine Delivery Pods® out of the reach and sight of children, as doses of nicotine that are tolerated by adult smokers can cause severe poisoning in small children and can be fatal.

Immediately telephone your doctor or the Poisons Information Centre: PH: 13 11 26 for advice or go to Accident and Emergency at the nearest hospital, in the event of overdose or suspected overdose.

After using SAABI Vaporised Nicotine Delivery System®.

Storage: Keep your pods in the pack inside the carton until you are ready to use it. If you take the pod out of the pack it may not keep well.

Store the pods below 25°C.

Do not store pods in the refrigerator, even in hot weather, as this could lead to leakage.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

KEEP OUT OF REACH OF CHILDREN

Disposal: If your pharmacist or doctor tells you to stop using SAABI Vaporised Nicotine Delivery System®, ask your pharmacist what to do with any pods that are left over.

Product Decription

What it looks like:

SAABI Vaporised Nicotine Delivery System® is available in 3 nicotine dosage strengths, each corresponding to a different pod strength

 

SAABI Nicotine Delivery Device. Battery 80mm x 20mm Black SAABI Nicotine Delivery Device®.

 

SAABI Nicotine Delivery Pods, 2% 20mg/ml: nicotine 20mg/ml/24 hours, POD 30mm x 1.8mm Black 20mg.

SAABI Nicotine Delivery Pods, 1.3% 13mg/ml: nicotine 13mg/ml/24 hours, POD 30mm x 1.8mm Black 1.3mg.

SAABI Nicotine Delivery Pods, 0% 0mg/ml: nicotine 0.0mg/ml/24 hours, POD 30mm x 1.8mm Black 0.0mg.

 

Ingredients: Active Ingredients: Nicotine Inactive Ingredients: Vegetable Glycerine (USP), Propylene Glycol (USP), Natural Flavours (GRAS)

Distributor:  SAABI Vaporised Nicotine Delivery System® is distributed in Australia by:

ANSPEC: 9-15 Chilvers Rd, Thornleigh NSW 2120, Australia. Tel: +61 2 8438 8600 Fax: +61 2 8438 8699  information please contact: domesticsales@anspec.com.auThis leaflet was prepared in Sep 2021

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AGE VERIFICATION